A Study of C105 on Cognitive Dysfunction in Persons With Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Dose-Titration Study to Assess the Safety, Tolerability, and Efficacy of C105 in Persons With Multiple Sclerosis With Cognitive Impairment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00529581
• Other study ID #: 22029
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2007
• Last updated: May 23, 2008
• Start date: November 2006
• Est. completion date: April 2008

Study information

• Verified date: May 2008
• Source: Cognition Pharmaceuticals, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the safety and efficacy of C105 in treating the cognitive deficits that can occur due to multiple sclerosis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: April 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Males/females at least 18 years old and < 65 years old, capable of understanding and complying with the protocol, including speaking and writing fluent English and having at least a 9th grade education

• Clinically definite diagnosis per McDonald criteria of Multiple Sclerosis as confirmed by the Investigator (Relapsing-Remitting or Secondary Progressive)

• Stable disease and relapse-free for > 90 days as verified by Investigator

• Presence of cognitive deficit as measured score of -1.5 SD on the SDMT (oral version) or a score of -1.0 SD on the SDMT and -1.0 SD on either CVLT-II (total learning or delayed recall) or PASAT

• EDSS <= 6.5

• Standard score of >79 on the WRAT-4 Reading test

• Have given written informed consent prior to any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to his/her future medical care

• Capable of performing the requirements of a neuropsychological test battery including having at least 20/70 near visual acuity by near vision chart, with correction (i.e., eyeglasses) allowed

• If female, must neither be pregnant nor breast-feeding and she must either (a) be > 12 months post-menopausal or surgically sterilized or (b) must agree to use an acceptable method of birth control (including hormonal contraceptives, intra-uterine device, or barrier methods such as condoms, diaphragm, etc. with spermicide) for the duration of the study. Abstinence will not be considered an acceptable method of birth control.

Exclusion Criteria:

• Subjects with memory deficits caused by concomitant medication usage or other significant neurological/psychological disease, e.g., Alzheimer's disease, Parkinson's disease, stroke, TIA, Multi-infarct dementia, Huntington's disease, head trauma, or chronic CNS infection

• Evidence of other medical cause of dementia

• Evidence of Major Depressive Disorder as determined by a Beck Fast Screen core of >3 and clinician interview

• Use of the following medications: Antipsychotic agents, Centrally acting appetite suppression drugs (e.g., sibutramine), CNS stimulants or drugs that metabolize to them (e.g., amantadine, Concerta, methylphenidate, Adderall, ephedrine, selegiline), Strattera (atomoxetine), Tricyclic antidepressants (e.g., amitriptyline), Herbal preparations including Ginkgo Biloba or containing Ephedra or other stimulants, MAO inhibitors. Note: other medications may be excluded or permitted, depending on length of treatment and stability of dose

• Uncontrolled or labile hypertension, or any clinically significant, unstable, or major concomitant disorder as determined by the Principal Investigator

• Active malignancy within one year of study participation

• Known human immunodeficiency virus (HIV)

• Current diagnosis of unstable glaucoma

• History of myocardial infarction of symptomatic Coronary Artery Disease

• Evidence of ongoing ischemia or uncontrolled atrial or ventricular arrhythmias as shown by ECG

• History of epilepsy or other seizure disorders

• Clinically significant motor or speech residual neurological deficits (e.g., hemiparesis, aphasia) that interfere with completion of study procedures

• Baseline clinical laboratory values indicative of a clinically significant co-morbidity

• Significant recent history of (within past 12 months) or current drug or alcohol abuse (as defined by DSM-IV)

• Known allergy or hypersensitivity to amphetamines or other sympathomimetic amines

• Participation in any clinical trial with an investigational drug within 30 days prior to randomization

• In the opinion of the Principal Investigator should not participate in the study

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cognition Disorders
• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• C105

Locations

Country	Name	City	State
United States	Neurology & Neuroscience Associates, Inc.	Akron	Ohio
United States	Shepard Center	Atlanta	Georgia
United States	The Jacobs Neurological Institute	Buffalo	New York
United States	Capitol Neurology	Charleston	West Virginia
United States	University of Virginia, Department of Neurology	Charlottesville	Virginia
United States	Riverhills Healthcare, Inc	Cincinnati	Ohio
United States	Associated Neurologists, P.C.	Danbury	Connecticut
United States	Henry Ford Health System, Department of Neurology	Detroit	Michigan
United States	Associated Neurologist of Southern Connecticut, PC	Fairfield	Connecticut
United States	MeritCare Neuroscience Clinic	Fargo	North Dakota
United States	Baylor College of Medicine	Houston	Texas
United States	University of Kansas Medical Center, Department of Neurology	Kansas City	Kansas
United States	Research Center for Clinical Studies West	Lancaster	California
United States	MidAmerica Neuroscience Institute	Lenexa	Kansas
United States	University of Kentucky	Lexington	Kentucky
United States	Loma Linda University, Department of Neurology	Loma Linda	California
United States	Neurology Associates, PA	Maitland	Florida
United States	Yale University MS Center	New Haven	Connecticut
United States	Saint Joseph's Hospital, Barrow Neurology Clinics	Phoenix	Arizona
United States	The Neurology Foundation, Inc.	Providence	Rhode Island
United States	Raleigh Neurology Associates	Raleigh	North Carolina
United States	Neurological Associates, Inc	Richmond	Virginia
United States	Central Texas Neurology	Round Rock	Texas
United States	Integra Clinical Research	San Antonio	Texas
United States	Lovelace Scientific Resources	Sarasota	Florida
United States	Roskamp Institute	Sarasota	Florida
United States	Suncoast Neuroscience Associates, Inc.	St. Petersburg	Florida
United States	Axiom Clinical Research of Florida	Tampa	Florida
United States	Northern Michigan Neurology	Traverse City	Michigan
United States	Northwest Neuro Specialists, PLLC	Tuscon	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Cognition Pharmaceuticals, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symbol Digit Modalities Test, Oral Version (SDMT) - Total # Correct		Change from baseline
Primary	Subject's Global Assessment of Cognitive Change		Change from baseline